Pregnancy after Endometrial Ablation is rare but associated with high maternal and neonatal morbidity

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Women undergoing Endometrial ablation should be informed that pregnancy is possible after the procedure and is associated with significant maternal and neonatal morbidity. She should be advised to use contraception after the procedure says the results of a systematic review published 27 September 2017 in British Journal of Obstetrics and Gynecology (BJOG).

This is the first systematic review published on this topic despite years of use of endometrial ablation for Abnormal Uterine Bleeding (AUB).  After a new technology is introduced, it takes years to come to know about unintended consequences and pregnancy is a late complication of EA.

This review by Kohn et al. reports 274 cases of pregnancy after endometrial ablation in median 1.5 years after the procedure (range 3 weeks – 13 years). The mean age of women was 37.5 ± 5(range 26-50 years). About 80-90% had not used any form of contraception, but the remaining does use some form of contraception.

1 in 4 pregnant women were amenorrhoeic after ablation.

About 4 out of every 5 pregnancies ended into miscarriage, ectopic or termination. Those who continued either had preterm labor, preterm premature rupture of membranes (PROM), morbidly adherent placenta, cesarean, cesarean hysterectomy and rupture of uterus. There was also higher incidence of neonatal complications like IUGR, prematurity, IUD or early neonatal demise.

Methods of doing Endometrial Ablation
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It was also seen that first generations ablation devices were more commonly used in clinical practice and have higher rates of less completely ablated endometrium, with lower rates of post-ablation amenorrhea and concomitant higher risk for subsequent pregnancy.

Physicians should explain in detail the risk of post-ablation pregnancy, using reliable contraception even if they are amenorrhoeic or perimenopausal.

In an accompanying commentary, Sharp HT focuses that physicians should think of alternative ways to treat AUB like levonorgestrel-containing intrauterine devices or delay ablation until completion of childbearing. If women still desire pregnancy after ablation, surrogacy or adoption can be a valid alternative.

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Commentary 

Cerene cryotherapy device for Endometrial ablation cleared for European market

ChannelMedsystems, the makers of Cerene cryotherapy endometrial ablation device today won the CE mark approval in the European union. The company is based at San Francisco, California, and the device is designed to treat premenopausal women with heavy menstrual bleeding who do not desire further pregnancies.

The Cerene Cryotherapy Device uses nitrous oxide, that freezes and destroy the surrounding endometrial tissue, thereby reducing scarring and intrauterine adhesions that are often associated with heat-based treatments.

Scarring and adhesions often lead to failure of procedure and reoperation. The cryothermic delivery system was incorporated into disposable, ergonomic device that can be held by hands thereby eliminating bulky equipments.

Earlier, in March 2017, Channel Medsystems, announced the successful completion of the treatment phase in its CLARITY Pivotal Study. The pivotal study evaluated the safety and efficacy of Cerene® Cryotherapy Device in 242 women with heavy menstrual bleeding who have already completed the family.

Ric Cote, President and CEO of Channel Medsystems said in a newsletter, ““From inception, our team has worked to understand what women and gynecologists are seeking in a new treatment for heavy menstrual bleeding. We’ve integrated that feedback into our development process and are excited that women in Europe will now have access to a treatment that is intended to meet their unique needs.”

“The introduction of the Cerene procedure in Europe will allow gynecologists to provide a new treatment option to their patients, one that may become more routine because it is designed to be more comfortable than traditional endometrial ablations, even without IV sedation or general anesthesia,” he further added.

Channel Medsystems endometrial cryoablation procedure animation video

Channel Medsystems completes pivotal study of Cerene® Cryotherapy Device for successful office based Endometrial ablation.

Cerene® Cryotherapy Device screenshot 

Channel Medsystems, a company based at Emeryville, CA announced the successful completion of the treatment phase in its CLARITY Pivotal Study. The pivotal study evaluated the safety and efficacy of Cerene® Cryotherapy Device in 242 women with heavy menstrual bleeding who have already completed the family.

Clarity study was a multisite study involving 8 locations in US along with few international locations. The study recruited its first participant in October 2016 and completed the study in just 5 months in early March 2017. The trial examined  parameters of comfort, recovery time and uterine healing for women undergoing  procedure.

The study participants were very enthusiastic about the treatment plan because the Cerene device, is designed to address women’s need for an effective, comfortable, office-based treatment with minimal to no downtime after the procedure.

Cerene® Cryotherapy Device screenshot

Cerene® Cryotherapy Device screenshot

“The Cerene cryoablation is a convenient, simple, and well-tolerated office procedure,” said Dr. Ted Anderson, Director of the Division of Gynecology at Vanderbilt University Medical Center and Investigator in the CLARITY study. “A patient can have this treatment the same way she has an IUD placed – in her gynecologist’s office with minimal pain management and very little discomfort. This has the potential to be a real game-changer for ablation.”

All women in the study were awake and responsive during the procedure, in contrast to heat ablation, allowing the investigators to collect data on pain scores throughout the therapy.

The Cerene Cryotherapy Device uses extreme cold to destroy tissue thereby reducing scarring and intrauterine adhesions that are often associated with heat-based treatments. Scarring and adhesions often lead to failure of procedure and reoperation. The cryothermic  delivery system was incorporated into disposable, ergonomic device that can be held by hands thereby eliminating bulky equipments.

The initial studies were presented  at 42nd American Association of Gynecologic Laparoscopists (AAGL)  Global Congress in Washington, D.C. in 2013. The subjects of initial studies were women who were scheduled for hysterectomy. The studies show that Channel Medsystems’ cryothermic therapy had an acceptable safety profile, can be performed in a clinically appropriate timeframe and was well-tolerated by the subject without the need for general anesthesia or conscious sedation.

The histopathogy specimen of the removed uteri showed selective   depth of ablation for  uterine cavity , cornua and lower uterine segment without compromising the function of uterine tissue. The results were parallel to currently-available hyperthermic therapies.

“Cerene is different from other endometrial ablation technologies I routinely use. Unlike current heat-based ablation devices, my patients actually relaxed once the two-and-a-half-minute treatment was initiated. This was a completely different treatment experience for me, my patients, and my staff,” lead investigator Dr. Jose Leal of Monterrey, Mexico’s Universidad Autónoma de Nuevo León said in a prepared statement.

This device is limited to investigational use in the US, Canada, and Mexico.

For more information visit the website www.channel medsystems.com.

        Channel Medsystems endometrial cryoablation procedure animation video

source: http://www.channel medsystems.com

Next- generation NovaSure ADVANCED endometrial ablation system launched in USA.

 

NovaSure ADVANCED

Hologic, Inc. today announced the launch of its next-generation, FDA approved NovaSure^® ADVANCED global endometrial ablation (GEA) system in the United States.

Hologic,Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. 

NovaSuresystem is designed to ablate the endometrium by applying radiofrequency energy to the endometrium thereby reducing the Abnormal Uterine Bleeding (AUB). It first received approval from FDA in 2001 and since then nearly 2 million women have been benefited by the procedure of endometrial ablation.

The new generation comes with smaller 6 mm Diameter sheath vs. 8 mm to improve patient comfort because of lesser cervical dilatation required for the procedure.

Additional feature of the updated device includes an acorn-like shaped cervical seal that creates an increased sealing surface within the cervical canal and provides 13% more "working length" than the previous model. It also includes rounded Smooth Access™ tips to simplify insertion that requires less manipulation and blue handle that serves as a useful reminder for how the device should be inserted.

The ablation procedure does not lasts more  than 2 minutes.

Dr. Edward Evantash, Medical Director, Hologic says "The next-generation NovaSure ADVANCED system promises the same efficacy and safety profile that physicians have trusted for more than 10 years."

The NovaSure ADVANCED system was launched in Europe, Canada and Australia in 2016.

NovaSure ADVANCED Product Demo

  

NovaSure ADVANCED Physician Testimonials